(Bloomberg) -- Johnson & Johnson, the world's largest health-products company, failed to ensure that heart stents made at a plant in Puerto Rico worked properly, U.S. regulators said.
The company's Cordis unit released devices to the market that didn't meet design specifications, the Food and Drug Administration said in a Feb. 16 warning letter released Tuesday. Two tests in 2009 found stents "did not completely expand," the agency said. Failure to fix violations may result in fines, product seizures or delayed device approvals, the FDA said.
J&J has lost ground to Abbott Laboratories and Boston Scientific Corp. in the $4 billion-a-year global market for stents, used to prop open arteries after de-clogging surgery. New Brunswick New Jersey-based J&J sold $627 million in drug- coated stents last year, compared with $919 million in 2009 and $2.62 billion in 2006, according to data compiled by Bloomberg.
"A critical device such as implantable stents must comply with their predetermined specification at the time of use to avoid complications with the surgical procedures and reduce patient risk," the FDA said in its letter to Seth Fisher, chairman of the Cordis group. The issues cited in the warning "may be symptomatic of serious problems," the FDA said.
J&J's Cypher stent, once the market leader, held 14 percent of worldwide sales in the fourth quarter, down from 20 percent a year earlier, Louise Mehrotra, J&J's vice president for investor relations, said on a Jan. 25 conference call. The company is seeking approval for a new catheter to help insert Cypher stents after its contract to use Abbott Park, Illinois-based Abbott's catheter expires in April.
The FDA's concerns in Puerto Rico may lead to approval delaysfor new stent products if the issues aren't fixed, said SandraPound, a spokeswoman for Cordis.
"We are currently working to address the questions raised," Pound said Tuesday in an e-mail. "We are confident our product remains safe and effective for use."